Lund, SWEDEN and Orebro, SWEDEN, Oct. 21, 2015 /PRNewswire/ -- Today, enrollment in the Instantaneous Wave-Free Ratio (iFR) versus Fractional Flow Reserve (FFR): A multicenter, prospective, randomized controlled clinical trial, iFR-SWEDEHEART, was completed.
The objective of iFR-SWEDEHEART is to clarify whether iFR is a clinically non-inferior strategy compared to FFR in assessment of the hemodynamic severity of coronary artery lesions. FFR carries a class Ia-guideline recommendation but requires administration of adenosine, a pharmaceutical associated with side effects. iFR is a novel method that does not require any hyperemic drugs but the method awaits clinical outcome data.
Enrollment started in May 2014 at Skane University Hospital, Sweden and 15 sites in Sweden, Denmark and Iceland have participated in the trial. In total, 2043 patients were randomized at a 1:1 ratio between iFR and FFR in an all-comers mixed cohort of stable angina and acute coronary syndrome. The study is investigator-initiated and has been funded by Volcano Europe, a Philips company, through a restricted research grant. Uppsala Clinical Research Center (UCR) acts as sponsor for the trial.
"We are very excited about the completion of enrollment and would like to extend our gratitude to all study sites for their commitment to the trial. We have managed to enroll the majority of patients with a clinical indication for functional assessment into a clinical trial using a registry-based randomized clinical trial (RRCT) design which enables much higher enrollment rates and is considerably more cost-effective than a classic randomized clinical trial design," say Matthias Gotberg, Coordinating Principal Investigator, and Ole Frobert, Chairman of the Steering Committee. The investigators expect to present the 12-month primary outcome data (death, MI and unplanned revascularization) during Spring 2017.
SOURCE Matthias Götberg